Insomnia
Conditions
Brief summary
The study is a randomized controlled trial evaluating the effect of bedtime music as an early intervention for sleep-onset insomnia in adults. The investigators use a randomized controlled trial design with two parallel groups. All participants receive sleep hygiene advice as standard treatment and participants in the intervention group are additionally asked to listen to a sleep playlist daily at bedtime. Subjective and objective sleep measures are evaluated before and after the 4 weeks intervention period. In addition, follow-up measures of subjective outcomes are assessed 4 weeks after the end of the intervention period.
Interventions
BEHAVIORALSleep hygiene advice
Participants receive standard sleep hygiene advice.
BEHAVIORALBedtime music listening
Participants in the intervention group listen to their preferred sleep playlist daily at bedtime for minimum 30 minutes.
Sponsors
University Hospital Heidelberg
University College Nordjylland
University of Oxford
Sygekassernes Helsefond
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Sleep-onset insomnia for 3-18 months
Exclusion criteria
1. use of medications (benzodiazepines, z-drugs, antidepressive and anti-psychotic drugs) 2. alcohol or substance abuse 3. pregnant or breastfeeding women 4. other sleep disorders (e.g. sleep apnea, restless leg syndrome, etc.) 5. current psychiatric disorder or a history of psychotic disorders 6. somatic disorders interfering with sleep (e.g. critical illness, pain disorders, neuro-degenerative disorders) 7. shift work.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia severity | Change from baseline to after the 4-week intervention period. | Measured with the Insomnia Severity Index, range 0-28 with higher scores indicating more severe insomnia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep quality | Change from baseline to after the 4-week intervention period. | Measured with the Pittsburgh Sleep Quality Index, range 0-21 with higher scores indicating more sleep problems. |
| Sleep initiation difficulties | Change from baseline to after the 4-week intervention period. | Difficulties initiating sleep as measured with Pittsburgh Sleep Quality Index subscale |
| Objective sleep quality | Change from baseline to after the 4-week intervention period. | Objective sleep quality as measured with polysomnography |
| Quality of life | Change from baseline to after the 4-week intervention period. | Quality of life as measured with SF-36, range 0-100 with higher scores indicating better quality of life. |
| Pre-sleep arousal | Change from baseline to after the 4-week intervention period. | Pre-sleep arousal as measured with the Pre-Sleep Arousal Scale, range 8-40 with higher scores indicating higher pre-sleep arousal. |
| Sleep-wake pattern | Change from baseline to after the 4-week intervention period. | Sleep-wake pattern as measured with wrist-actigraphy |
Other
| Measure | Time frame | Description |
|---|---|---|
| Depressive symptoms | Change from baseline to after the 4-week intervention period. | Depressive symptoms as measured with Beck Depression Inventory II, range 0-63 with higher scores indicating more severe depression. |
| Anxiety | Change from baseline to after the 4-week intervention period. | Anxiety as measured with the State-Trait Anxiety Inventory, range 0-80 with higher scores indicating more anxiety. |
Countries
Denmark
Outcome results
None listed